Drug recall
Apheresis Pooled Cryoprecipitated AHF
FDA recall event 78496 · Class II, Class III · New York Blood Center, Inc.
Key facts
| Event ID | 78496 |
|---|---|
| Recall numbers | B-0205-2018, B-0206-2018, B-0207-2018 |
| Recalling firm | New York Blood Center, Inc. |
| Product type | Biologics |
| Products | Apheresis Pooled Cryoprecipitated AHF, Blood and Blood Products for Reprocessing, Red Blood Cells, Leukocytes Reduced |
| Classification | Class II, Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. |
| Initiation date | Oct 5, 2017 |
| Report date | Dec 27, 2017 |
| Termination date | Dec 21, 2017 |
| City | New York |
| State | NY |
| Country | United States |
| FEI number | 2476837 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: